To assess the effectiveness of intraoperative intra oral sonography for adequate margin resection of tongue cancer, in a semi experimental clinical trial we divided patients in two groups. in one group the tumor resection during surgery is done by conventional method, the surgeon palpated the tumor margins and with 1-1.5 cm margin resect the tumor. in other group the surgeon uses intraoral sonography to determine the tumor margins, in this method tumor is seen hypoecho. with needle we can mark the tumor margin and then resect it.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111030811N1
Registration date:2017-04-04, 1396/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-04, 1396/01/15
Registrant information
Name
Ebrahim Karimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 6106
Email address
ebkarimi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
non
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intraoperative intraoral sonography for tumor margin determination in T1-T2-T3 tongue cancer
Public title
intraoperative intraoral sonography for tongue cancer resection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who have oral cancer stage T1-T2-T3
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics committee
Street address
Tehran University of Medical Sciences, Keshavarz boulevard
City
Tehran
Postal code
1417653761
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.TUMS.MEDICINE.REC. ۱۳۹۵.۷۱۷
Health conditions studied
1
Description of health condition studied
Tongue cancer
ICD-10 code
C02
ICD-10 code description
Malignant neoplasm of other and unspecified parts of tongue
Primary outcomes
1
Description
Surgical margin
Timepoint
intraoperative
Method of measurement
positive or negative in pathology report
Secondary outcomes
empty
Intervention groups
1
Description
Intraoperative intraoral sonography for tongue cancer resection
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Mahdokht sadat Manavi
Street address
Tehran-Darvazeh Dowlat
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
Qods street, Keshavarz boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdokht sadat Manavi
Position
Otolaryngology resident
Other areas of specialty/work
Street address
Darvazeh Dowlat
City
Tehran
Postal code
Phone
+98 21 6670 8103
Fax
Email
mahdokht_mnv@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdokht sadat Manavi
Position
Otolaryngology resident
Other areas of specialty/work
Street address
Darvazeh Dowlat
City
Tehran
Postal code
Phone
+98 21 6670 8103
Fax
Email
mahdokht_mnv@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdokht sadat Manavi
Position
Otolaryngology resident
Other areas of specialty/work
Street address
Darvazeh Dowlat
City
Tehran
Postal code
Phone
00
Fax
Email
mahdokht_mnv@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)